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CompletedNCT03786770Updated Feb 16, 2023Results posted

Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)

A Phase 2 interventional study of DaxibotulinumtoxinA for injection in Frown Lines, sponsored by Revance Therapeutics, Inc.. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-16.

Sponsored by Revance Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
61
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.

02

Conditions studied

  • Frown Lines

Keywords

  • Forehead Lines
  • Glabellar Lines
  • Frown Lines
03

In context

Lead sponsor

Revance Therapeutics, Inc. is the lead sponsor of 29 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Provide written informed consent consistent with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
  • Be outpatient, male or female subjects, in good general health, 18-65 years of age
  • Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS)
  • Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Patient Forehead Wrinkle Severity (PFHWS)
  • Have a score of moderate (2) or severe (3) GL during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
  • Have a score of moderate (2) or severe (3) on GL during maximum frown as assessed by the Patient Frown Wrinkle Severity (PFWS)
  • Be willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling, or a product that may cause an active dermal response in the treatment areas (e.g., above the inferior orbital rim) from screening through the end of the study
  • Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion criteria

Exclusion Criteria:

  • Active skin disease, infections, or inflammation at the injection sites
  • Plans to receive botulinum toxin type A anywhere in the face (other than study treatment) from screening through the end of the study
  • History of clinically significant bleeding disorders
  • Non-ablative laser or light treatments, microdermabrasion, or chemical peels (medium depth or deeper, for example trichloroacetic acid (TCA) or phenol) in the treatment areas within 3 months before enrollment through the end of the study
  • Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study as determined by the investigator
  • History of upper or lower lid blepharoplasty or brow lift
  • Prior periorbital or forehead surgery
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Cohort 1: Dose A

    DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

    Biological: DaxibotulinumtoxinA for injection

  • Experimental
    Cohort 2: Dose B

    DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

    Biological: DaxibotulinumtoxinA for injection

  • Experimental
    Cohort 3: Dose C

    DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

    Biological: DaxibotulinumtoxinA for injection

  • Experimental
    Cohort 4: Dose D

    DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

    Biological: DaxibotulinumtoxinA for injection

Interventions

  • BiologicalDaxibotulinumtoxinA for injection

    Intramuscular injection

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation

    Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.

    Time frame: Week 4 After FHL Treatment

07

Results

Posted Feb 16, 2023

Participant flow

Participant flow — Overall Study
MilestoneCohort 1: DAXI 40 U GL / 12 U FHLCohort 2: DAXI 40 U GL / 18 U FHLCohort 3: DAXI 40 U GL / 24 U FHLCohort 4: DAXI 40 U GL / 30 U FHL
Started14151616
Completed13151616
Not completed1000

Outcome measures

PrimaryPercentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation

Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.

Time frame:
Week 4 After FHL Treatment
Reported as:
Number · percentage of subjects
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
percentage of subjectsCohort 1: DAXI 40 U GL / 12 U FHLCohort 2: DAXI 40 U GL / 18 U FHLCohort 3: DAXI 40 U GL / 24 U FHLCohort 4: DAXI 40 U GL / 30 U FHL
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation85.786.793.8100

Adverse events

Collected over The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1: DAXI 40 U GL / 12 U FHL0/14 (0%)0/14 (0%)5/14 (35.7%)
Cohort 2: DAXI 40 U GL / 18 U FHL0/15 (0%)0/15 (0%)5/15 (33.3%)
Cohort 3: DAXI 40 U GL / 24 U FHL0/16 (0%)0/16 (0%)5/16 (31.3%)
Cohort 4: DAXI 40 U GL / 30 U FHL0/16 (0%)0/16 (0%)5/16 (31.3%)
Most frequent other events
Showing 10 of 19
Most frequent other events
EventCohort 1: DAXI 40 U GL / 12 U FHLCohort 2: DAXI 40 U GL / 18 U FHLCohort 3: DAXI 40 U GL / 24 U FHLCohort 4: DAXI 40 U GL / 30 U FHL
OedemaGeneral disorders2/144/152/160/16
ErythemaSkin and subcutaneous tissue disorders1/144/151/161/16
HeadacheNervous system disorders0/142/151/161/16
AsthenopiaEye disorders1/140/150/160/16
Eyelid ptosisEye disorders1/140/150/160/16
Muscle strainInjury, poisoning and procedural complications1/140/150/160/16
Ear infectionInfections and infestations0/141/150/160/16
Tooth infectionInfections and infestations0/141/150/160/16
Blood glucose increasedInvestigations0/141/150/160/16
Head discomfortNervous system disorders0/141/150/160/16

Baseline characteristics

Intent to treat population

Age, Categorical
Age, Categorical(Participants)Cohort 1: DAXI 40 U GL / 12 U FHLCohort 2: DAXI 40 U GL / 18 U FHLCohort 3: DAXI 40 U GL / 24 U FHLCohort 4: DAXI 40 U GL / 30 U FHLTotal
<=18 years00000
Between 18 and 65 years1415161560
>=65 years00011
Age, Continuous
Age, Continuous(years)Cohort 1: DAXI 40 U GL / 12 U FHLCohort 2: DAXI 40 U GL / 18 U FHLCohort 3: DAXI 40 U GL / 24 U FHLCohort 4: DAXI 40 U GL / 30 U FHLTotal
Mean49 (37 to 62)48.1 (34 to 60)47.8 (26 to 62)45.6 (28 to 65)47.6 (26 to 65)
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1: DAXI 40 U GL / 12 U FHLCohort 2: DAXI 40 U GL / 18 U FHLCohort 3: DAXI 40 U GL / 24 U FHLCohort 4: DAXI 40 U GL / 30 U FHLTotal
Female1014151554
Male41117
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort 1: DAXI 40 U GL / 12 U FHLCohort 2: DAXI 40 U GL / 18 U FHLCohort 3: DAXI 40 U GL / 24 U FHLCohort 4: DAXI 40 U GL / 30 U FHLTotal
Race — White1415151559
Race — Black/African American00101
Race — Other00011
08

Study locations

4 sites
  • Boca Raton site
    Boca Raton, Florida 33431, United States
  • Coral Gables site
    Coral Gables, Florida 33146, United States
  • Toronto, Ontario site
    Toronto, Ontario M5R3N8, Canada
  • Woodbridge, Ontario site
    Woodbridge, Ontario L4L8E2, Canada
09

References and documents

Study documents

  • Study protocol · Mar 4, 2019
  • Statistical analysis plan · Apr 6, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03786770
Lead sponsor
Revance Therapeutics, Inc.
Responsible party
Sponsor
First posted
Dec 26, 2018
Start date
Jan 24, 2019
Primary completion
Mar 9, 2020
Completion
Mar 9, 2020
Results posted
Feb 16, 2023
Last update
Feb 16, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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